1. Healthcare

Micromedic Reports Successful Clinical Study
Results for Monitoring Bladder Cancer Recurrence
with the CellDetect® Non-Invasive Test
- Plans to Secure CE Mark for a European Launch of the Non-Invasive Test and
Submit a Pre-IDE to the U.S. FDA in 2015 –
TEL-AVIV (February 2, 2015) - Micromedic Technologies Ltd. (TASE: MCTC),
announced today the results of a blinded, multi-center clinical study using the
CellDetect® non-invasive technology to detect bladder cancer recurrence in patients
with a history of the disease. The CellDetect® test successfully identified cancerous
cells in urine samples, with reported sensitivity of 84.4% and specificity of 82.7% for
the study’s primary endpoint. The blinded clinical study was conducted in nine
medical centers, where urine samples from 217 subjects with a history of bladder
cancer were tested. The study population included 121 healthy subjects and 96
patients currently suffering from the disease.
The results of the CellDetect® urine test were compared with results from biopsy or
cystoscopy, in cases where biopsies were not performed. The results also indicated
that the negative predictive value (NPV) was 98.5%. In addition to its high sensitivity
for advanced stage tumors and high-grade malignancy, the test was also found to
exhibit high sensitivity for early stage tumors and low-grade malignancies which are
difficult to identify using other non-invasive tests currently available on the market.
The secondary endpoint showed that the sensitivity of other non-invasive comparator
tests, urine cytology, BTA stat and NMP22 BladderCheck, was 50.0%, 68.8% and
17.4%, respectively. These findings indicate that the method is adequately sensitive
for the purpose of accurate and early detection of the recurrence of the disease.
Following these successful study results, the company plans to secure a CE mark
approval for a European launch of this non-invasive test later this year as well as to
submit a Pre-IDE to the U.S. Food and Drug Administration (FDA).
“We are tremendously pleased with the results of the study that confirm the high
performance of the CellDetect® urine test in accurately monitoring recurrence of
bladder cancer" Steven Eitan, Micromedic’s CEO, said. “By administering this test,
millions of bladder cancer patients may be able to forego numerous costly and
invasive tests, starting to receive treatment faster if their cancer is likely to recur.
Following these successful results, we are also planning to conduct the required
activities to quickly broaden the intended use to the early detection diagnostic market
for additional millions of patients . The CellDetect® technology has the potential for
diagnosing additional cancer indications.”
Prof. Ofer Yossepowitch. M.D., Head of the Uro-Oncology Service at Rabin Medical
Center: “The study results are encouraging. The accuracy of this novel assay appears
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to be superior over any available non-invasive test, suggesting a potential to supplant
some or all of the cystoscopies required for bladder cancer surveillance. This is indeed
great news for patients with history of bladder cancer, which may change their
management.”
About CellDetect®
Micromedic’s CellDetect® technology allows an accurate diagnosis of cancerous and
precancerous cells based on unique combination of color and morphology. The
technology may be implemented in screening and monitoring cancer patients.
Micromedic has proven the product’s efficacy in diagnosing cervical cancer and
bladder cancer in the framework of clinical trials, and estimates that the technology
underlying the products may be implemented for use in additional cancer indications.
The cervical cancer detection screening diagnostic test kit is in the initial commercial
stage and Micromedic recently completed a clinical trial to prove its ability to monitor
bladder cancer recurrence. Micromedic believes that the underlying technology may
be adapted for other types of cancer as well.
About Bladder Cancer
Bladder cancer is the fourth most prevalent cancer among males in the U.S and
seventh globally with nearly 430,000 new cases of the disease diagnosed worldwide
in 2012. The rate of recurrence is the highest of all cancers and ranges from 50% to
80%. Because of high recurrence rates, the cost of diagnosing and treating bladder
cancer is among the highest of all cancers.
About Micromedic
Micromedic is engaged in the development and commercialization of unique solutions
addressing a real need prevailing in the field of cancer diagnostics including early
detection of cancers.
For more information please visit the Company’s website at www.m-medic.com
CONTACTS:
Micromedic
Steven Eitan, CEO ([email protected])
Tel: +972-73-2753450